U.S. Sen. Bill Cassidy (R-LA), chairman of the U.S. Senate Health, Education, Labor, and Pensions (HELP) Committee, on Feb. 17 released a committee report detailing legislative and regulatory reforms to modernize the U.S. Food and Drug Administration (FDA).
The HELP Committee’s proposals in “Patients and Families First: Building the FDA of the Future” aim to maintain American biomedical dominance and ensure patients have timely access to the latest life-saving treatments.
“Biomedical innovation holds enormous promise for the American people… But ‘innovation’ is meaningless unless it creates products that actually help patients,” Sen. Cassidy writes in the report’s introduction.
“The FDA has enormous leverage over how to channel breakthroughs that can make Americans’ lives better,” he continued. “While many parts of FDA work well, unnecessary bottlenecks slow patients and consumers getting the products they need.”
In the report, the HELP Committee makes several recommendations to improve the FDA, including by eliminating red-tape and increasing predictability in the FDA review process.
This includes making it easier to bring low-cost generic drugs to market, and integrating artificial intelligence (AI) and other technologies in the review process to expedite approval while still ensuring safety.
The committee also recommends ensuring families have safe, healthy foods by bolstering the FDA’s Human Foods Program, and keeping medical research stateside rather than in China by streamlining clinical trials and encouraging collaboration between FDA and developers.
Additionally, the FDA’s workforce could become stronger by incentivizing the best American scientists and experts to serve at the agency, according to the recommendations.
“Ultimately, it should be easier to make Americans healthy by empowering them with the tools and information they need to make healthy choices and live better lives,” writes Sen. Cassidy. “The HELP Committee looks forward to coordinating with FDA under its new leadership to promote patient access, accelerate U.S. competitiveness, and improve the health of American families.”
He added that the HELP Committee plans to initiate a collaborative, bipartisan process for FDA reforms and to get better and more affordable products to patients faster, saying the report reflects initial input from a variety of stakeholders, including patient advocates, academic researchers, clinical societies, manufacturers, the FDA, and more.